Precautions The device is intended or single use only. Mechanical power aspiration with a continuous vacuum source and large lumen aspiration catheter was first introduced in the neurovascular space when Penumbra revolutionized thrombus removal for acute ischemic stroke patients. Indigo Aspiration Catheters (CAT) are the foundation of Penumbras IndigoSystem. With S. Jay Mathews, MD, MS, FACC; Chris Metzger, MD; Waqas R. Qureshi, MD, MS; Jawairia Sahar K. Mirza, MBBS; Gus Theodos, MD, FACC, FSCAI; Brian Kolski, MD; and Suhail Dohad, MD, FACC. These pages are not intended for patients or for members of the general public. She had acute tubular necrosis with minimal urine output at the time of transfer. Possible complications include, but are not limited to, the following: allergic reaction and anaphylaxis from contrast media; acute occlusion; air embolism; arteriovenous fistula; death; device malfunction; distal embolization; emboli; false aneurysm formation; hematoma or hemorrhage at access site; inability to completely remove thrombus; infection; hemorrhage; ischemia; kidney damage from contrast media; neurological deficits including stroke; vessel spasm, thrombosis, dissection, or perforation; intimal disruption; myocardial infarction; emergent surgery; fibrillation; hypotension; respiratory failure; peripheral thromboembolic events. Possible complications include, but are not limited to, the following: acute vessel occlusion; air embolism; allergic reaction and anaphylaxis from contrast media or device material; anemia; arrhythmia; arteriovenous fistula; cardiac injury, cardiac perforation, cardiac tamponade; cardio-respiratory arrest; compartment syndrome; death; emboli; emergent surgery; foreign body embolization; hematoma or hemorrhage at access site; hemoptysis; hemorrhage; hypotension/hypertension; infarction leading to organ damage; infection; ischemia; myocardial infarction; neurological deficits including stroke; pneumothorax; pseudoaneurysm; renal impairment or acute renal failure from contrast media; residual thrombus due to inability to completely remove thrombus or control blood flow; respiratory failure; valvular damage; vessel spasm, thrombosis, dissection (intimal disruption), or perforation. Do not use in an oxygen rich environment. . N Engl J Med. TIMI 3 flow was achieved in 88% of cases. Separator 8, 150 cm Length, 0.072 in. Disclosures: None. If the device is forcefully retracted at extreme angles during removal from the packaging, damage such as this may occur. Penumbra Aspiration Pump The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems. Get Penumbra Cat 8 in Secunderabad, Hyderabad, Telangana at best price by Zephyr Technologies. This allowed prompt treatment of patients with minimal intensive care unit days and early discharge from the hospital. Disclaimer: The opinions and clinical experiences presented herein are for informational purposes only. After IVUS, the stent was dilated to 3.75 mm. Contraindications There are no known contraindications. Enter your email address and we will contact you. When performing aspiration, ensure that the INDIGO Aspiration Tubing is open for only the minimum time needed to remove thrombus. The final angiographic outcome revealed complete revascularization and TIMI 3 flow (Figure 2). Vedantham S, Goldhaber SZ, Julian JA, et al. These data are encouraging and have led to the next stage in data collection through the CHEETAH studya 400-patient, prospective, observational study evaluating the initial safety and performance of the Indigo Aspiration System CAT RX. Penumbra's CAT family of catheters is engineered to be robust, trackable, atraumatic, and well suited to the peripheral anatomy where clots can form in long segments. The built-in microprocessor features a proprietary thrombus removal algorithm that automatically controls a valve in the tubing to provide continuous or intermittent aspiration. Order Qty. Reuse may result in canister cracking or vacuum filter blockages, which may result in the inability to aspirate. If repositioning of the INDIGO Aspiration Catheter is necessary during the revascularization procedure, such repositioning should be performed over an appropriate guidewire using standard catheter and guidewire techniques. Potential Adverse Events Do not use the Indigo Aspiration System with a pump other than the Penumbra Aspiration Pump. Within 72 hours, repeat echocardiography showed RV/LV ratio improvement from 1.43 to 0.98. 0 cm from the distal tip. Do not use open or damaged packages. Each vessel was wired sequentially, delivering power aspiration via CAT RX to the site of each thrombus. This website is intended for US audience only. Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 12 inches (30 cm) to any part of LIGHTNING Aspiration Tubing. This is potentially more effective than diminished syringe-based aspiration. Its engineers designed low-profile, high-power aspiration catheters called Cat 7 and Cat 12 that were launched in 2021. Possible complications include, but are not limited to, the following: These benefits may suggest a reduction to cost of care, improved patient outcomes, and changes to the procedural algorithm. 1. The INDIGO SEPARATOR 4 is not intended for use as a guidewire. Final angiogram showing resolution of extensive thrombus burden. The combination of intelligent aspiration and large-lumen catheter engineering form Lightning 7 and Lightning 12: the latest generation in clot removal technology. Maintain a constant infusion of appropriate flush solution. The means of mains disconnect is to remove the power cord. Caution: Federal (USA) law restricts this device to sale by or on the order of a physician. Disclosures: None. Indigo System Intended Use The device is intended for single use only. INDIGO System LIGHTNING Aspiration Tubing Intended Use The Penumbra ENGINE is intended as a vacuum source for Penumbra Aspiration Systems. Brian Kolski, MD Penumbra Aspiration Pump: The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems. Jolly SS, Cairns JA, Yusuf S, et al. Created with Sketch. Presented at: American College of Cardiologys 68th Annual Scientific Session; March 1618, 2019; New Orleans, LA. Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the Penumbra ENGINE. As part of the Indigo Aspiration System, the Indigo CAT RX Aspiration Catheters and Indigo Separator 4 are indicated for the removal of fresh, soft emboli and thrombi from vessels in the coronary and peripheral vasculature. Launches Indigo System Lightning 12 in U.S. Appoints Corey L. Teigen, M.D., as Chief Scientific Officer and James F. Benenati, M.D., FSIR, as Chief Medical Officer Penumbra, Inc. (NYSE: PEN), a global healthcare company focused on innovative therapies, today announced its next phase for vascular franchise growth with U.S. commercial availability of the Indigo System Lightning 12 and . Do not resterilize or reuse. CHEETAH will focus on patients presenting with high-grade thrombus burden who receive frontline treatment with CAT RX. . Do not use in the presence of a flammable anesthetic mixture with air or nitrous oxide. Prior to use, please refer to the Instructions for Use for complete product indications, contraindications, warnings, precautions, potential adverse events, and detailed instructions for use. (CAT3, CAT RX, CAT5, CAT6, CAT8, and CATD) and patented Separator technology, which maintains continuous aspiration and helps limit clogging of the catheters tip during the procedure. In some cases, we have also seen a reduction in glycoprotein IIb/IIIa inhibitor usage (which may be associated with higher rates of bleeding). The deliverability and continuous aspiration power were essential to achieving restoration of flow supporting a positive patient outcome to help heal this case of CLI. This ability of lobar thrombectomy likely allowed EXTRACT-PE to be the first endovascular IDE, pulmonary embolism trial that has reported statistically significant reduction in on-table systolic pulmonary artery pressures. Available in a selection of sizes, the CAT family can provide access to distal peripheral vessels of the upper and lower extremities, including below the knee. Copyright 2022 Penumbra, Inc. All rights reserved. Available in a selection of sizes, the CAT family can provide access to distal peripheral vessels of the upper and lower extremities, including below the knee. Precautions The device is intended for single use only. Penumbra ENGINE Intended Use The Penumbra Indigo System Separator is intended for use with our Indigo Systems CAT family of catheters to enable the removal of a wide range of thrombus. These were quickly followed by the release of the 8-F CAT8 and 6-F CAT6 in 2015. A Penumbra CAT8 catheter was placed into the right upper lobe, right middle lobe, and right lower lobe, and aspiration with a separator was performed. 2. Medical Director, Aortic Disease and Ischemic Limb Disease Do not use in an oxygen rich environment. Director of Cardiac & Peripheral Cath Lab The procedure can be performed quickly,1 which is important for symptomatic patients. Do not position the PENUMBRA ENGINE so that it is difficult to remove the power cord. For more information on the personal data that is collected by this website, please refer to Penumbras Privacy Notice. Using the usual telescoping technique of the sheath, the CAT8 and SEP8 were used in tandem to aspirate the thrombus using sustained aspiration with Penumbra ENGINE. Figure 2. Final angiogram after mechanical thrombectomy with CAT8 and SEP8. For more information on the personal data that is collected by this website, please refer to Penumbras Privacy Notice. Excessive aspiration or failure to close the INDIGO Aspiration Tubing when aspiration is complete is not recommended. Penumbra CAT8XTORQ115 CAT8 Indigo System Aspiration Catheter 8F Item Past Expiration. The complaint indicated that the cat8 was kinked during the procedure. N Engl J Med. Penumbra has issued an urgent recall of all configurations of the Penumbra JET 7 Reperfusion Catheter with Xtra Flex Technology (JET 7 Xtra Flex) based on the risk of unexpected death or serious . With reperfusion to the distal vasculature and clear visualization of the underlying stenosis, a 3.5-mm stent was placed. 0 cm from the hub. Prior to use, please consult device labeling and instructions for use. After one pass with CAT RX, the initial occlusion was removed. window.dataLayer = window.dataLayer || []; Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 12 inches (30 cm) to any part of LIGHTNING Aspiration Tubing. The Indigo Aspiration System is contraindicated in: Manual aspiration using a Pronto V3 (Teleflex) catheter restored some flow, however, distal embolization to the posterior descending artery (PDA) immediately caused right ventricular cardiac arrest (Figure 2). When performing aspiration, ensure that the INDIGO Aspiration Tubing valve is open for only the minimum time needed to remove thrombus. The Indigo System CAT3, CAT5, CAT6, CAT8 and CATD ?are engineered to be robust, durable, and trackable for use in the peripheral anatomy. Use the Indigo Aspiration System in conjunction with fluoroscopic visualization. gtag('js', new Date()); Not for use in the coronaries or the neurovasculature. After one pass with CAT RX, the high thrombus burden was removed, resulting in TIMI 3 flow. CAT RX has allowed us to rethink how we approach these occluded SVGs. CAT7 and CAT12 are the next generation of the Indigo System Catheters. Maintain a constant infusion of appropriate flush solution. If repositioning of the INDIGO CAT RX Aspiration Catheter is necessary during the revascularization procedure, such repositioning should be performed over an appropriate guidewire using standard guidewire techniques. As part of the Indigo Aspiration System, the Indigo CAT RX Aspiration Catheters and Indigo Separator 4 (Penumbra, Inc.) are indicated for the removal of fresh soft emboli and thrombi from vessels in the coronary and peripheral vasculature. Suhail Dohad, MD, FACC Precautions The device is intended for single use only. The product-specific content of this website is intended for use by healthcare professionals only. IN-DATE. The product-specific content of this website is intended for use by healthcare professionals only. Common emitters (such as RFID emitters, security systems, diathermy equipment, and portable transmitters) should not be used in close proximity to the Penumbra ENGINE as they can interfere with and result in degradation of the performance of the equipment. INDIGO Aspiration Catheters and Separators: As part of the INDIGO Aspiration System, the INDIGO Aspiration Catheters and Separators are indicated for the removal of fresh, soft emboli and thrombi from vessels of the peripheral arterial and venous systems, and for the treatment of pulmonary embolism. She was in a rehab facility prior to this new event recovering from her CVA. Peripheral Thrombectomy Indigo System Mechanical Thrombectomy CAT6 Indigo Catheter 6, Straight tip 135cm. Tip directionality for circumferential aspiration, Live feedback during procedure with integrated clot catcher, Penumbra ENGINE is capable of delivering and maintaining nearly pure vacuum (-29 inHg or 98.2 kPa) with the disposablePenumbra ENGINE Canister. This press release features multimedia. 1. Reuse may result in canister cracking or vacuum filter blockages, which may result in the inability to aspirate. Penumbra CAT8XTORQ115 CAT8 Indigo System Aspiration Catheter 8F Item Past Expiration +1(833)330-3033. Do not use automated high-pressure contrast injection equipment with the INDIGO Aspiration Catheter because it may damage the device. Tip directionality for circumferential aspiration, Live feedback during procedure with integrated clot catcher, Penumbra ENGINE is capable of delivering and maintaining nearly pure vacuum (-29 inHg or 98.2 kPa) with the disposablePenumbra ENGINE Canister. Available in a selection of sizes, the CAT family can provide access to distal peripheral vessels of the upper and lower . Continuous Aspiration Mechanical Thrombectomy Catheters (CAT) are the foundation of Penumbra's Indigo System. The CAT familyof catheters is the foundation of Penumbras Indigo System. waqas.qureshi@umassmemorial.org Units in stock: 1. Penumbras Indigo Aspiration System can be used to remove emboli and thrombi from vessels of the peripheral arterial and venous systems, and for the treatment of pulmonary embolism and/or certain central circulatory system conditions such as pulmonary emboli. Unit may overheat and shut off or fail to restart if run for extended periods without airflow. With the maximized inner diameter of 0.082 and a 7 French outer diameter, CAT7 is 93% the size of CAT8, now with a lower profile. This website is intended for US audience only. The Indigo system CAT3, CAT5, CAT6, CAT8 and CATD are engineered to be robust, trackable, atraumatic and well suited for the peripheral anatomy. gtag('js', new Date()); The procedure time was short (median of 37 minutes)the shortest demonstrated so far in an investigational device exemption (IDE) trial on patients with pulmonary embolism. Do not advance, retract or use any component of the Indigo Aspiration System against resistance without careful assessment of the cause using fluoroscopy. Available in a selection of sizes, the CAT family can provide access to distal peripheral . Final angiogram after stent placement showing resolution of underlying disease. It is intended for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusions. Missouri Baptist Medical Center Director, Structural Heart Lightning 12 and Lightning 8 expand the already broad offering of CAT8, CATD, CAT6, CAT5, and CAT3 and are paired with Penumbra ENGINE, the company's proprietary continuous, mechanical vacuum . All Rights Reserved Privacy Policy, With S. Jay Mathews, MD, MS, FACC; Chris Metzger, MD; Waqas R. Qureshi, MD, MS; Jawairia Sahar K. Mirza, MBBS; Gus Theodos, MD, FACC, FSCAI; Brian Kolski, MD; Suhail Dohad, MD, FACC. The initial angiogram confirmed a distal occlusion of the RCA with TIMI 0 flow and extensive clot burden (Figure 1). The Indigo System utilises the Penumbra ENGINE aspiration source capable of delivering nearly pure, continuous vacuum (-29 inHg or 98.2 kPa) to our catheters, enabling thrombus removal in vessels of various sizes. The penumbra cat8 indigo system (cat8) was kinked approximately 4. Copyright 2023 Penumbra, Inc. All rights reserved. $399.00 EACH. Return all damaged devices and packaging to the manufacturer/distributor. Disclosures: Consultant to Penumbra, Inc. A 75-year-old woman with a history of diabetes, hypertension, and dyslipidemia presented with Rutherford class 5 critical limb ischemia (CLI) due to a nonhealing ulcer. Figure 2. Potential Adverse Events The catheters (CAT3, CAT RX*, CAT5, CAT6, CAT8, CATD) vary in diameters from 3.4 to 8 F and lengths of 50 to 150 cm to . Use the INDIGO Aspiration System in conjunction with fluoroscopic visualization. Next Article Do not use automated high-pressure contrast injection equipment with the Indigo CAT RX Aspiration Catheter because it may damage the device. Maintain a constant infusion of appropriate flush solution. The sustained aspiration power provided by the Penumbra ENGINE allowed rapid TIMI 3 flow restoration and removal of the distal emboli. Contraindications 0, and 37. Please email info@medicalmaterials.com or call us at 877-663-8686 and we will try to locate the product with our suppliers. Her heart rate was 110 beats per minute, elevated troponin levels at 4.5 ng/mL, and elevated brain natriuretic peptide at 1,164 pg/mL. Otherwise, this could result in degradation of the performance of this equipment. o The Penumbra Indigo System Separator is intended for use with our Indigo System's family of catheters to enable the removal of a wide range of thrombus. Catheters & Separators. Throughout each case, Lightning provides procedural feedback via audio visual cues. The Indigo Separator is advanced and retracted through the corresponding size Indigo catheter at the proximal margin of the primary occlusion to facilitate clearing of the thrombus from the catheter tip. The system uses Penumbra's RED reperfusion catheters. The cat8 was kinked approximately 69. CAT8XTORQ115KIT-NS. Chris Metzger, MD Resterilization and/or reuse may result in ineffective catheter coating lubrication, which may result in high friction and the inability to access the target vasculature location. The Indigo System is intended for the removal of fresh, soft emboli and thrombi from vessels of the peripheral and venous systems, and certain central circulatory systems conditions such as pulmonary emboli, using continuous aspiration. The Indigo system CAT3, CAT5, CAT6, CAT8 and CATD are engineered to be robust, trackable, atraumatic and well suited for the peripheral anatomy. Mechanical thrombectomy was performed. INDIGO Aspiration Tubing: A 65-cm 8-F Destination sheath (Terumo Interventional Systems) was advanced into the right pulmonary artery, first over a telescoping balloon tip catheter and stiff angle Glidewire (Terumo Interventional Systems). Resterilization and/or reuse may result in ineffective catheter coating lubrication, which may result in high friction and the inability to access the target vasculature location. Penumbra ENGINE Indication For Use Indigo System CAT RX tracking through the distal posterior tibial artery. CAT8 Indigo Aspiration Catheter 8, TORQ tip, 85cm , 8Fr., Peripheral Thrombectomy Mechanical one eachCAT8 Indigo Aspiration Catheter 8, TORQ tip, 85cm , 8Fr., Peripheral Thrombectomy Mechanical one eachCAT8 Indigo Aspiration Catheter 8, TORQ tip, 85cm , 8Fr., Peripheral . Smidt Heart institute 5, 21. The Indigo Aspiration System is intended for the removal of fresh, soft emboli and thrombi from vessels of the peripheral arterial and venous systems and certain central circulatory system conditions such as pulmonary emboli using continuous aspiration. Indication For Use Los Angeles, California She had normal left ventricular systolic function with severe right ventricular dysfunction on her echocardiogram. The atraumatic tip and small catheter French size of the CAT8 device allows for easy tracking and maneuvering through the vasculature and selective debulking of thrombus from lobar branches of the pulmonary arterial tree. UMassMemorial University Campus It will reduce the service life of the PENUMBRA ENGINE. function gtag(){dataLayer.push(arguments);} QUICK VIEW. INDIGO Aspiration System Intended Use indicated to connect the INDIGO CAT RX Aspiration Catheters to the Penumbra Aspiration Pump. Since launch, we have found that CAT RX has become an essential part of our treatment algorithm when thrombus is present in the coronaries. In our practice, we have been able to more accurately define percutaneous transluminal coronary angioplasty and stent length as a result of this increased visualization. 5 and 94. The CAT family of catheters is the foundation of Penumbra's Indigo system. The INDIGO SEPARATOR is not intended for use as a guidewire. excellent trackability, and similar power to the CAT8 Penumbra catheter that was previously used for this . Presented at: Vascular InterVentional Advances (VIVA); November 47, 2019; Las Vegas, Nevada. Figure 3. Catheters; CAT8 KIT Indigo System Aspiration Catheter 8 and Aspiration Tubing - XTORQ - 8Fr x 115cm . The cerebral vasculature 1.10 Summary of Non-Clinical Data As required under Section 12, Part (a)(i)(3A) of the Safe Medical Devices Act of 1990, a Further evaluation of the returned device revealed kinks in the catheter shaft. Do not block bottom air vents. If the cause cannot be determined, withdraw the device or system as a unit. Indigo Aspiration Catheters (CAT) are the foundation of Penumbra's Indigo System. Copyright 2022 Penumbra, Inc. All rights reserved. Pela bainha, foi introduzido o dispositivo de aspirao Penumbra Indigo System CAT8 XTORQ (Penumbra Inc., Alameda, Califrnia, Estados Unidos) em trombo segmentar, lobar ou arterial pulmonar principal, sendo realizada aspirao contnua (Figuras 2 e 3). The large aspiration lumen and highly trackable, low-profile design coupled with the power of the Penumbra ENGINE resulted in the successful removal of the emboli in one pass. Two passes of CAT RX with the Penumbra ENGINE resulted in TIMI 3 flow restoration and retrieval of the distal emboli from the PDA (Figure 3). The newest indication for the Indigo System is the treatment of pulmonary embolism; this indication comes on the heels of the promising results of the EXTRACT-PE trial. Penumbra introduced the Ruby Coil in 2013, followed by the launch of PODin 2014 and Packing Coil in 2015. There was an immediate response in the clinical situation of the patient: her blood pressure stabilized into the 90s and her oxygenation improved substantially. The Indigo SystemCAT3, CAT5, CAT6, CAT8 and CATD are engineered to be robust, durable, and trackable for use in the peripheral anatomy. suhail.dohad@cshs.org Penumbra's Indigo Aspiration System, launched in 2014, is designed to remove clot from arteries and veins in the peripheral vasculature, and for treatment of pulmonary embolism. Do not use in oxygen rich environment. The Indigo System CAT RX was the preferred choice for mechanical aspiration thrombectomy to remove the distal emboli below the knee in the posterior tibial artery. Use only waterbased solvents for cleaning. The Indigo Aspiration System is comprised of several devices: The Indigo System may be used as a first-line approach or rescue therapy for arterial and venous thrombotic events. Distal posterior tibial artery emboli occlusion. Lightning 7 expands Penumbra's offering of the Indigo Aspiration System with Intelligent Aspiration for mechanical thrombectomy and is designed for single session arterial thrombus removal. Mechanical power aspiration with the Indigo System CAT RX (Penumbra, Inc.), introduced in 2018, continues to gain in popularity as a solution for high thrombus burden in the coronaries. Contraindications There are no known contraindications. A minimally-invasive device, Indigo enables the restoration of blood flow in such cases as acute limb ischemia and venous thrombus. Results of EXTRACT-PE Trial presented at Vascular InterVentional Advances (VIVA) Annual Meeting Penumbra, Inc. (NYSE: PEN), a global healthcare company focused on innovative therapies, today announced that the EXTRACT-PE trial successfully met the primary endpoints, demonstrating the safety and efficacy of the Indigo Aspiration System for aspiration mechanical thrombectomy in patients with . No conversations found. The Indigo Aspiration System is intended for the removal of fresh, soft emboli and thrombi from vessels of the peripheral arterial and venous systems and certain central circulatory system conditions such as pulmonary emboli using continuous aspiration. St. Joseph Hospital For more information on the personal data that is collected by this website, please refer to Penumbras Privacy Notice. Do not advance, retract or use any component of the INDIGO System against resistance without careful assessment of the cause using fluoroscopy. Possible complications include, but are not limited to, the following: Initial experience with a mechanical aspiration catheter for thrombus removal during percutaneous intervention: a multicenter retrospective case series. 2: Add Do not advance, retract or use any component of the INDIGO Aspiration System against resistance without careful assessment of the cause using fluoroscopy. Penumbras IndigoAspiration System, launched in 2014, is designed to remove clot from arteries and veins in the peripheral vasculature, and for treatment of pulmonary embolism. Potential Adverse Events Equipment is not safe for MR use. Orange, California allergic reaction and anaphylaxis from contrast media; acute occlusion; air embolism; arteriovenous fistula; death; device malfunction; distal embolization; emboli; false aneurysm formation; hematoma or hemorrhage at access site; inability to completely remove thrombus; infection; hemorrhage; ischemia; kidney damage from contrast media; neurological deficits including stroke; vessel spasm, thrombosis, dissection, or perforation; intimal disruption; myocardial infarction; emergent surgery; fibrillation; hypotension; respiratory failure; peripheral thromboembolic events. Excessive aspiration or failure to close the INDIGO Aspiration Tubing valve when aspiration is complete is not recommended. Lightning comes packaged with the Indigo CAT7, CAT8 or CAT12. The Indigo Separator is advanced and retracted through the corresponding size Indigo catheter at the proximal margin of the primary occlusion to facilitate clearing of the thrombus from the catheter tip. In patients with submassive pulmonary embolism with compromised right ventricular function and elevated biomarkers, the Indigo System is an excellent frontline tool offering a safe and effective1 treatment option. Caution: Prior to use, please refer to the Instructions for Use for complete product indications, contraindications, warnings, precautions, potential adverse events, and detailed instructions for use. 2017;377:2240-2252. Engineered with neuro-tracking technology, CAT RX is designed to navigate tortuous anatomy and track to distal coronary vasculature while maintaining sustained mechanical aspiration with the Penumbra ENGINE. The Indigo Separator 4 is not intended for use as a guidewire. allergic reaction and anaphylaxis from contrast media; acute occlusion; air embolism; arteriovenous fistula; death; device malfunction; distal embolization; emboli; false aneurysm formation; hematoma or hemorrhage at access site; inability to completely remove thrombus; infection; hemorrhage; ischemia; kidney damage from contrast media; neurological deficits including stroke; vessel spasm, thrombosis, dissection, or perforation; intimal disruption; myocardial infarction; emergent surgery; fibrillation; hypotension; respiratory failure; peripheral thromboembolic events. Available in a selection of sizes, the CAT family can provide access to distal peripheral vessels of the upper and . SVG occlusions can be challenging to resolve using traditional treatment modalities. Return all damaged devices and packaging to the manufacturer/distributor. The CAT family of catheters is the foundation of Penumbra's Indigo system. Contraindications There are no contraindications. The laser-cut, reinforced hypotube catheters have a soft, atraumatic tip . Prior to use, please consult device labeling and instructions for use. The Indigo System CAT3, CAT5, CAT6, CAT8, CATD, and CAT7D are engineered to be robust, trackable, atraumatic, and well suited for the peripheral anatomy. Utility of a power aspiration-based extraction technique as an initial and secondary approach in the treatment of peripheral arterial thromboembolism: results of the multicenter PRISM Trial.
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